MitraClip™ CDS0801-NTWRecalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 05415067050748), received between Jun 12, 2025 and Sep 21, 2026 — classified as 1 death, 37 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Incomplete Coaptation” (20 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Incomplete Coaptation

  It was reported on (b)(4) 2026 that the patient presented with grade 4 degenerative mitral regurgitation (MR), short and calcified leaflet, enlarged atrium and thin leaflet for a MitraClip procedure. During the procedure, a MitraClip was successfully implanted.Post deployment, the clip had single leaflet device attachment (SLDA) from the posterior leaflet. The MR remained unchanged post procedure. There was no clinically significant delay or adverse patient effects reported.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 50843373 ↗
• InjurySep 18, 2026Incomplete Coaptation

  It was reported on (b)(6) 2026 that the patient presented with grade 4 degenerative mitral regurgitation (MR), calcified anterior leaflet for a MitraClip procedure. During the procedure, a MitraClip NTW was successfully implanted.Post deployment, the clip NTW had single leaflet device attachment (SLDA) from the anterior leaflet. An attempt was made to deploy another MitraClip for stabilization. However, the clip was removed from the anatomy due to sub-optimal imaging. The MR was reduced to grade 3-4 post procedure. There was no clinically significant delay reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829540 ↗
• MalfunctionAug 11, 2026Unintended Movement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50211522 ↗
• InjuryAug 7, 2026Break; Positioning Failure; Premature Activation; Difficult to Remove; Unintended Movement

  It was reported that on (b)(6) 2026, a patient presented with grade 4+ functional mitral regurgitation (MR), restricted anterior and posterior leaflet for a Mitraclip procedure. During the procedure, first mitraclip was implanted. Second mitraclip was inserted and it got stuck to the guide tip. It was unable to get the grasp and teared a chord. Physician was trying to remove the undeployed clip from the patient, and clip appeared to be moving in an unfavorable path and interacted with the guide, and the mandrel broke and the clip separated. Lockline was still in place. Cardiothoracic (CT) surgeon was consulted. It was decided to pull the guide and clip across septum from left atrium to right atrium. Guide and clip were lowered together to the lower inferior vena cava. Clip remained closed and attached to the lock line. Left groin access was obtained and snare was obtained. Clip was snared in the inferior vena cava from the left. Clip was off the lockline. Clip delivery system and guide was removed from the right groin. 24Fr Inari guide was inserted on the right. Snared clip was pulled into the left groin. Second snare was inserted into the right groin and clip was snared. Clip was

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50174169 ↗
• InjuryJul 31, 2026Incomplete Coaptation

  It was reported on (b)(6) 2026 that the patient presented with grade 4 degenerative mitral regurgitation (MR) for a MitraClip procedure. During the procedure, 2 MitraClips were successfully implanted. The MR was reduced to grade 2 post procedure.On (b)(6) 2026, follow up revealed that one clip had single leaflet device attachment (SLDA) from the posterior leaflet. Recurrent MR of grade 3-4+ was reported along with dyspnea. There was no clinically significant delay reported.

  Patient problems: Dyspnea; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 50100356 ↗
• InjuryJul 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT MITRAL REGURGITATION (MR). A MITRACLIP WAS INSERTED AND DEPLOYED ON THE MITRAL VALVE, REDUCING MR. HOWEVER, AN INCREASE IN PRESSURE GRADIENT WAS OBSERVED. ON AN UNKNOWN DATE, POST PROCEDURE, A TRANSTHORACIC ECHOCARDIOGRAM (TTE) REVEALED MODERATE TO SEVERE STENOSIS. IT WAS NOTED THAT THE PHYSICIAN WAS FIRST NOTIFIED THAT A TENDYNE TRANSCATHETER MITRAL VALVE REPLACEMENT WAS NOT POSSIBLE IN THE FIRST COMMUNICATION REGARDING THIS PATIENT. HOWEVER, THE SCREENING REVEALED A BORDERLINE ANATOMICAL CASE THAT MAY HAVE BEEN POSSIBLE FOR TENDYNE, AND THE PHYSICIAN WAS NOT NOTIFIED OF THIS UNTIL AFTER THE MITRACLIP PROCEDURE, WHICH UPSET THE PHYSICIAN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Valve Stenosis

  MAUDE report 25857871 ↗
• MalfunctionJul 10, 2026Difficult to Open or Close

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 3-4 MIXED MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, FIRST MITRACLIP WAS INSERTED BUT WAS REMOVED AS THERE WAS CHANGE IN THE CLIP SELECTED. SECOND CLIP DELIVERY SYSTEM (CDS) WAS INSERTED INTO THE PATIENT AND POSTERIOR GRIPPER WOULD NOT LOWER. TROUBLESHOOTING WAS PERFORMED BUT WAS UNSUCCESSFUL. THIRD CLIP WAS ATTEMPTED BUT WAS NOT IMPLANTED DUE TO THE CHALLENGING IMAGING. CLIP WAS REPLACED AND CONTINUED THE PROCEDURE. ALL STEPS WERE PERFORMED AS PER IFU. THE FINAL MR WAS GRADE 3-4. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25780640 ↗
• InjuryJul 7, 2026Entrapment of Device; Migration

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL MITRAL REGURGITATION (MR), ROTATED HEART AND RESTRICTED ANTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. IMAGING WAS SUB-OPTIMAL DUE TO PATIENT'S COMPLEX ANATOMY. DURING THE PROCEDURE, ONE MITRACLIP WAS IMPLANTED. POST DEPLOYMENT, THE SECOND CLIP WAS PARTIALLY DETACHED FROM THE ANTERIOR LEAFLET. ADDITIONAL CLIP WAS DEPLOYED TO STABILIZE THE SECOND CLIP. PER THE PHYSICIAN, THE PARTIAL DETACHMENT WAS CAUSED DUE TO THE PRESENCE OF CHORDS IN THE CLIP ARM WHEN GRASPING ATTEMPTS WERE MADE. THE MR WAS REDUCED TO GRADE 2 POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25737880 ↗
• MalfunctionJun 30, 2026Difficult or Delayed Activation

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A MITRACLIP NTW WAS SUCCESSFULLY ADVANCED INTO THE PATIENT AND PLACED ON THE LEAFLETS. DURING DEPLOYMENT THE MANDREL DID NOT DISCONNECT FROM THE CLIP AFTER TURNING THE ACTUATOR KNOB AND RAISING THE GRIPPERS. TROUBLESHOOTING WAS PERFORMED BY GENTLY ROCKING THE GUIDE AND TURNING THE ACTUATOR KNOB RELEASE TWICE. THE MANDREL WAS THEN SUCCESSFULLY REMOVED FROM THE CLIP AND THE CLIP WAS IMPLANTED SUCCESSFULLY. THE PROCEDURE WAS DISCONTINUED; THE FINAL MR WAS REDUCED TO GRADE 1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25669207 ↗
• MalfunctionJun 25, 2026Premature Activation; Improper or Incorrect Procedure or Method; Difficult to Open or Close

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR), A DILATED LEFT ATRIUM, AND RESTRICTED, CALCIFIED LEAFLETS FOR A MITRACLIP PROCEDURE. IMAGING WAS SUB-OPTIMAL DUE TO PATIENT'S COMPLEX ANATOMY. DURING THE PROCEDURE, A MITRACLIP WAS SUCCESSFULLY IMPLANTED. POST DEPLOYMENT, THE CLIP HAD SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) FROM THE ANTERIOR LEAFLET. ANOTHER MITRACLIP NTW WAS PREPARED FOR DEPLOYMENT TO STABILIZE THE SLDA CLIP. DURING PREPARATION, THE RELEASE PIN WAS PREMATURELY PULLED, AND UPON TESTING THE CLIP ARMS, THE DEVICE WAS UNABLE TO OPEN. AS A RESULT, A MITRACLIP NT WAS OPENED; HOWEVER, DURING PREPARATION, THE CLIP WAS ALSO UNABLE TO OPEN FOLLOWING RAISING THE GRIPPERS AND UNLOCKING OF THE CLIP. SUBSEQUENTLY, A MITRACLIP XTW WAS DEPLOYED TO STABILIZE THE SLDA CLIP. ANTERIOR LEAFLET WAS OBSERVED TO BE DAMAGED POST SLDA. POST-PROCEDURE, THE MR WAS REDUCED TO GRADE 2. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25621424 ↗
• MalfunctionJun 15, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR), RESTRICTED POSTERIOR LEAFLET AND HAD ENDOCARDITIS FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, MITRACLIP WAS IMPLANTED. THE FINAL MR WAS GRADE 1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED. ON (B)(6) 2026, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED, AND IT WAS DETERMINED THAT THERE WAS A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) AND THE CLIP WAS NO LONGER ATTACHED TO THE POSTERIOR LEAFLET. MR WAS GRADE 4 AFTER SLDA. ON (B)(6) 2026, ADDITIONAL MITRACLIP NTW WAS IMPLANTED ON THE MEDIAL SIDE OF FIST CLIP TO STABILIZE THE SDLA. GRASPING WAS DIFFICULT. UPON DEPLOYMENT, IT WAS DETERMINED THAT THERE WAS A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) AND THE CLIP WAS NO LONGER ATTACHED TO THE POSTERIOR LEAFLET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25506181 ↗
• MalfunctionJun 9, 2026Incomplete Coaptation

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, IMAGING WAS SUB-OPTIMAL DURING GRASPING OF LEAFLETS. A MITRACLIP WAS SUCCESSFULLY IMPLANTED. THE MR WAS REDUCED TO GRADE 1 POST PROCEDURE. ON (B)(6) 2026, THE CLIP SINGLE LEAFLET DEVICE ATTACHMENT(SLDA) FROM THE ANTERIOR LEAFLET. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25449706 ↗
• MalfunctionJun 8, 2026Difficult to Open or Close

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A STEERABLE GUIDE CATHETER (SGC) WOULD NOT HOLD THE COLUMN. SGC WAS REMOVED FROM THE PATIENT AND NOTICED THAT AIR WAS PRESENT. SGC WAS REPLACED. IT WAS OBSERVED THAT ONE OF THE GRIPPERS WOULD NOT LOWER FOR MITRACLIP NTW. PROCEDURE WAS DISCONTINUED. ALL STEPS WERE PERFORMED AS PER IFU. THE FINAL MR WAS GRADE 4. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25436342 ↗
• InjuryJun 8, 2026Premature Activation; Difficult to Open or Close

  IT WAS REPORTED ON (B)(6) 2026, THAT THE PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL MITRAL REGURGITATION (MR) AND RESTRICTED POSTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, THE STEERABLE GUIDE CATHETER (SGC) WAS ADVANCED INTO THE LEFT ATRIUM, FOLLOWED BY ADVANCEMENT OF THE CLIP. AFTER ADVANCEMENT, AN ATTEMPT WAS MADE TO OPEN THE CLIP; HOWEVER, THE CLIP FAILED TO OPEN DESPITE TROUBLESHOOTING MANEUVERS. AS A RESULT, AN ATTEMPT WAS MADE TO REMOVE THE CLIP FROM THE ANATOMY. DURING THIS PROCESS, IT WAS NOTED THAT THE CLIP HAD DETACHED FROM THE CLIP DELIVERY SYSTEM (CDS). A SNARE WAS UTILIZED TO RETRIEVE THE CLIP, FOLLOWED BY BALLOON DILATION OF THE SEPTUM TO FACILITATE WITHDRAWAL OF THE SNARED CLIP INTO A NON-ABBOTT SHEATH. THE CLIP WAS SUCCESSFULLY REMOVED FROM THE ANATOMY. DURING PREPARATION OF SECOND CLIP, THE CLIP WAS UNABLE TO PASS ESTABLISH FINAL ARM ANGLE TEST (EFAA) AS THE CLIP JUMPED OPEN TO 120 DEGREE. THE CLIP WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE MR WAS REDUCED TO GRADE <1 POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25430968 ↗
• MalfunctionMay 15, 2026Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A MITRACLIP NTW WAS SUCCESSFULLY ADVANCED WITHIN THE PATIENT AND PLACED ON THE LEAFLETS. THE LOCK WAS TESTED AND THE CLIP OPENED. THERE WERE CHALLENGES WITH VISUALIZING THE CLIP. TROUBLESHOOTING WAS ATTEMPTED BUT WAS UNSUCCESSFUL. THE CLIP WAS REMOVED AND A REPLACEMENT MITRACLIP WAS SELECTED AND IMPLANTED SUCCESSFULLY. AFTER THE PROCEDURE, IT WAS DIFFICULT TO REMOVE THE STEERABLE GUIDE CATHETER (SGC) FROM THE STABILIZER. THE SGC WAS REMOVED FROM THE PATIENT, STILL ATTACHED TO THE STABILIZER. TROUBLESHOOTING WAS PERFORMED, AFTER SIGNIFICANT FORCE THE SGC WAS REMOVED FROM THE STABILIZER. THE FINAL MR WAS REDUCED TO GRADE 1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25191417 ↗
• InjuryMay 11, 2026Positioning Failure

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 3-4 MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, THERE WAS CHALLENGES GRASPING THE LEAFLETS. TROUBLESHOOTING WAS PERFORMED, AND THE LEAFLET WAS TORN. THE CLIP WAS ATTEMPTED TO BE PLACED; THERE WAS NO CHANGE IN MR SO THE CLIP WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS DISCONTINUED, THE FINAL MR REMAINED AT GRADE 2-4. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation; Unspecified Tissue Injury

  MAUDE report 25143888 ↗
• InjuryMay 11, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL MITRAL REGURGITATION (MR), DILATED LEFT ATRIUM AND LEFT VENTRICLE, THICKENED CALCIFIED LEAFLETS AND CONGESTIVE HEART FAILURE (CHF) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, MITRACLIP NTW WAS IMPLANTED ON LATERAL SIDE OF ANTERIOR AND POSTERIOR LEAFLET 2(A2/P2). POST DEPLOYMENT, IT WAS DETERMINED THAT THERE WAS A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) AND THE CLIP WAS NO LONGER ATTACHED TO THE ANTERIOR LEAFLET. IMAGING WAS DIFFICULT. ADDITIONAL MITRACLIP NT WAS IMPLANTED ON CENTRAL SIDE OF ANTERIOR AND POSTERIOR LEAFLET 2 (A2/P2) TO STABILIZE THE SLDA. THE FINAL MR WAS GRADE 1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25142448 ↗
• MalfunctionMay 4, 2026Leak/Splash

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4+ DEGENERATIVE MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PREPARATION, IT WAS OBSERVED THAT THE FLUID POURING FROM THE ACTUATOR KNOB AND ARM POSITIONER. TROUBLESHOOTING WAS PERFORMED BUT WAS UNSUCCESSFUL. DEVICE WAS REPLACED AND CONTINUED THE PROCEDURE. THE FINAL MR WAS GRADE 1+. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071460 ↗
• MalfunctionApr 27, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, ONE MITRACLIP WAS IMPLANTED SUCCESSFULLY. AFTER DEPLOYMENT, IT WAS DETERMINED THAT THERE WAS A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) AND THE CLIP WAS NO LONGER ATTACHED TO THE POSTERIOR LEAFLET. THE FINAL MR WAS GRADE 2+. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25008662 ↗
• MalfunctionApr 27, 2026Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4+ MIXED MITRAL REGURGITATION (MR) AND PROLAPSED ANTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, UPON PREPARING FOR DEPLOYMENT, LOCK WAS TESTED AND CLIP CONTINUED TO OPEN ABOUT 20 DEGREES. TROUBLESHOOTING WAS PERFORMED BUT WAS UNSUCCESSFUL. CLIP WAS REMOVED FROM THE PATIENT AND WAS REPLACED WITH NEW MITRACLIP NTW. ALL STEPS WERE PERFORMED AS PER IFU. THE FINAL MR WAS GRADE 2. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25008527 ↗
• InjuryApr 27, 2026Incomplete Coaptation

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL MITRAL REGURGITATION (MR), AND RESTRICTED POSTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A MITRACLIP WAS SUCCESSFULLY IMPLANTED. FIRST MITRACLIP HAD SINGLE LEAFLET DEVICE ATTACHMENT(SLDA) FROM THE POSTERIOR LEAFLET. PER THE PHYSICIAN, THE SLDA DUE TO THE PRE-EXISTING PATIENT ANATOMY OF THIN AND TETHERED LEAFLETS. ANOTHER MITRACLIP WAS IMPLANTED TO STABILIZE THE SLDA CLIP. THE MR WAS REDUCED TO GRADE <1 POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25008500 ↗
• MalfunctionApr 20, 2026Retraction Problem

  IT WAS REPORTED THAT DURING PREPARATION OF A MITRACLIP NTW CLIP DELIVERY SYSTEM (CDS), AFTER ATTACHING THE DRIP LINE, THE SLEEVE OF THE CLIP DELIVERY SYSTEM (CDS) WOULD NOT RETRACT FROM THE HANDLE. THEREFORE, THE CLIP WAS NOT USED AND WAS REPLACED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927879 ↗
• MalfunctionApr 10, 2026Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, IT WAS NOTICED THAT THE STEERABLE GUIDE CATHETER WAS BENT WHEN DEVICE WAS REMOVED FROM THE PATIENT. THE BEND IN THE GUIDE CAUSED IRREGULAR CLIP MANEUVERS. CLIP HAD LATERAL TO MEDIAL DIVE DESPITE HAVING NO M-KNOB APPLIED. IT WAS TRIED TO APPLY L-KNOB TO CORRECT IT, WHICH WAS NOT EFFECTIVE. THE DIVE WAS NOT OPTIMAL BUT MANAGEABLE TO COMPLETE THE PROCEDURE. ALL STEPS WERE PERFORMED AS PER IFU. THE FINAL MR WAS GRADE 1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839349 ↗
• MalfunctionApr 7, 2026Premature Activation; Difficult to Remove; Difficult to Open or Close; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, GRASPING WAS MADE AND MEAN GRADIENT WAS TOO HIGH TO IMPLANT THE CLIP, IT WAS DECIDED TO REMOVE THE CLIP AND DISCONTINUE THE PROCEDURE DUE TO SMALL VALVE AREA. CLIP WAS INVERTED AND RETRACTED INTO THE LEFT ATRIUM. CLIP WAS THEN LOCKED, CLOSED TIGHTLY TO RETRACT IT INTO THE GUIDE. UPON RETRACTING THE CLIP INTO THE GUIDE, CLIP WAS CAUGHT AT THE SOFT TIP OF THE GUIDE, AND THE CLIP WAS SPRUNG OPENED TO ABOUT 120 DEGREES AND GOT DISCONNECTED FROM THE MANDREL. PHYSICIAN WAS ABLE TO RETRACT ONE CLIP ARM INTO THE GUIDE AND PULL THE GUIDE AND THE CLIP DELIVERY SYSTEM TOGETHER, BACK INTO THE SEPTUM AND INTO THE RIGHT ATRIUM. IT WAS PULLED DOWN THE GROIN AND OUT OF THE PATIENT SUCCESSFULLY. THE FINAL MR WAS GRADE 4. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24802119 ↗
• InjuryMar 30, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) AND ROTATED HEART FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, FIRST MITRACLIP WAS IMPLANTED. IT WAS DETERMINED THAT THERE WAS SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) HAS OCCURRED AND THE CLIP WAS NO LONGER ATTACHED TO THE POSTERIOR LEAFLET. PER THE PHYSICIAN, SLDA WAS DUE TO THE PRE-EXISTING PATIENT ANATOMY OF CHORDAL ENTANGLEMENT. ADDITIONAL MITRACLIP WAS IMPLANTED TO STABILIZE THE SLDA. IMAGING WAS DIFFICULT. THE FINAL MR WAS GRADE 1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24717108 ↗